In May last year, Bose received 510(k) clearance from the US Food and Drug Administration (FDA) for first of their kind, over-the-counter (OTC) hearing aids. Since then, the audio equipment manufacturer has faced mixed public opinions on expanding its market reach into the notoriously underpenetrated hearing aids market. Despite the carefully limited initial launch of its SoundControl Hearing Aids and setting a far more affordable price-point against its competitors, the challenges of capturing adequate market share had proven to be unsustainable for Bose, resulting in its quiet exit from the market earlier this month.

Bose has historically focused on consumer products within the audio industry like headphones and speakers, often leading the industry with new technologies, most notably active noise cancellation. More recently, the company developed the opposing technological application of sound amplification technology, as it saw a market opportunity for treating millions of adults with mild to moderate hearing loss.

Analysis by GlobalData reveals the enormous numbers of global prevalent cases of hearing losses, which exceed hundreds of millions. Even when accounting for just the US, the potential becomes apparent for a MedTech company, or even an untraditional one like Bose, to tap into its market for growing its hearing aid sales that do not require surgeries the way cochlear or middle ear implants do. Despite the enormous addressable market, the hearing aids market has historically faced significant reluctance among its potential users. This is especially true among older patients who make up most cases, where their self-reliance and desire to maintain their earlier lifestyle become obstacles to product adoption. Even for patients whose biases do not dictate their choices, the sheer unaffordability of hearing aids prices many of them out.

Most medical devices, especially when made available over the counter, do not face much reluctance given the health and wellness benefits that patients can enjoy. Given the hearing aid market’s relatively unique position within the MedTech market, Bose had most likely overestimated its ability to draw new patients to cement itself as the sole player within the OTC hearing aids market. This also serves as a reminder of the many challenges companies face when expanding into new markets, especially when attempting to initially monopolise them.

According to GlobalData, there are currently more than 50 companies worldwide marketing more than 430 hearing aids, with most sales based in the US and Europe. While no other company has taken on OTC hearing aids since Bose’s departure, the broader growth and innovation of consumer medical devices will likely catalyse increasing volumes of OTC product launches, including hearing aids.

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By GlobalData